THG performance enhancer used by athletes is "unapproved new drug", says FDA

ROCKVILLE, MD., October 28, 2003 -- The FDA reported that it had
recently been made aware of a substance called tetrahydrogestrinone
(THG), which is reportedly used by athletes to improve their
performance. Based on the agency's analysis of this product, FDA
has determined that THG is an unapproved new drug. As such, it
cannot be legally marketed without FDA approval under the agency's
rigorous approval standards that are meant to ensure that drugs
that are sold to American consumers are safe and effective.

FDA is concerned about the marketing and use of this unapproved
product and is working with other Federal law enforcement agencies
to aggressively engage, enforce, and prosecute those firms or
individuals who manufacture, distribute, or market THG.

"Our mission is to protect the American public from this
potentially harmful product," said John Taylor, FDA's Associate
Commissioner for Regulatory Affairs.

In the meantime, FDA is warning consumers that while little is
formally known about the safety of this drug, its structure and
relationship to better known products leads FDA to believe that its
use may pose considerable risks to health. Although purveyors of
THG may represent it as a dietary supplement, in fact it does not
meet the dietary supplement definition. Rather, it is a purely
synthetic "designer" steroid derived by simple chemical
modification, from another anabolic steroid that is explicitly
banned by the U.S. Anti-Doping Agency.

The use of THG by athletes, as an alternative to other banned
anabolic steroids, was recently disclosed by the U.S. Anti-Doping
Agency. This substance is closely and structurally related to two
other synthetic anabolic steroids, gestrinone and trenbolone.
Anabolic steroids, which build muscle mass, can have serious
long-term health consequences in men, women, and children.